ObesityNCT07139795
The Mind-Body Project
A study testing Mindful eating and movement in people with Obesity, run by Northeastern University at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to learn if a combined mindful eating and mindful movement (yoga) program is feasible and acceptable for people with overweight/obesity. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Mindful eating and movement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >18 years of age
- Body Mass Index (BMI) > 27 kg/m2
- Ambulatory
- Ability to read, write, and understand English
- Intention to remain in the Boston area for the duration of the study
- Good or corrected vision and hearing
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- Not currently enrolled in a physical activity or nutrition study
- Affiliated with Northeastern as a student, faculty, staff, or alumni
- No participation in a weight loss study in the past 12 months
- Willingness to participate in all study measurements and activities of their assigned group
- Ability to provide informed consent
- No bariatric surgery in the past five years or plans for bariatric surgery within the study period
Who cannot join
- < 18 years of age
- BMI < 27 kg/m2
- Non-ambulatory (i.e., use of walkers, wheelchairs)
- Participation in a weight loss study in the past 12 months
- Currently enrolled in a different physical activity or nutrition study
- Significant problems with vision or hearing
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- Unwilling to participate in all study measurements and/or activities of their assigned group
- Participation in guided yoga sessions in the past three months
- Adults not affiliated with Northeastern as a student, faculty, staff, or alumni
- Current cancer diagnosis and going through active treatment (chemotherapy, radiation)
- Pregnant, breastfeeding, or plans to become pregnant during the three-month intervention
- Inability to provide informed consent
- Bariatric surgery within the past five years or plans for bariatric surgery within the study period
Trial locations and contacts
1 site in 1 country.
United States1 site
Northeastern University
Boston, Massachusetts, 02115
About this study
The goal of this pilot clinical trial is to learn if a combined mindful eating and mindful movement (yoga) program is feasible and acceptable for people with overweight/obesity. The main questions it aims to answer are:
- What is the feasibility and acceptability of an 8-week mindful eating and yoga intervention for adults with overweight/obesity?
- Does the program bring about changes in mindfulness, dietary behaviors, and physical activity?
- Does the program lead to positive changes in body composition, and key biomarkers of blood sugar and lipids assessed via a blood panel using a finger stick procedure (no venous blood draw).
Read more
Researchers will compare the 8-week mindful eating and movement intervention to a waitlist control group.
Participants will:
Be assigned to the 8-week intervention or waitlist group. Participate 2x/week in the mindful eating and movement sessions. Complete assessments of feasibility and acceptability as well as self-report and objective assessments describe above.
- Conditions
- Obesity
- Being tested
- Mindful eating and movement
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful eating and movementBehavioural
Group mindful eating sessions will be conducted once per week, one hour per session, for eight weeks. Participants will be encouraged to attend at least two, 45-minute yoga sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will engage in group mindful eating sessions 1x/week for 75 minutes. Participants will be encouraged to attend at least 2x/week, 45-minute yoga sessions. Receives: Behavioral: Mindful eating and movement |
| Waitlist Control | No intervention | Participants assigned to the waitlist control group will complete all baseline and follow-up assessments at the same time as the intervention group. They will receive the same 8-week program after the completion of all assessments by all participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events.
Measured: Primary endpoint: 8-weeks
Acceptability
Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)
Measured: Primary endpoint: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start18 Aug 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northeastern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neha Gothe, Northeastern University
- Investigators
- Neha P Gothe, PhD, MA, MS, Principal investigator, Northeastern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139795
- Sponsor's protocol ID
- IRB:25-06-24
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mind-Body Project
- ClinicalTrials.gov ID
- NCT07139795
- Acronym / sponsor ID
- IRB:25-06-24
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Northeastern UniversityUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot clinical trial is to learn if a combined mindful eating and mindful movement (yoga) program is feasible and acceptable for people with overweight/obesity. The main questions it aims to answer are:
- What is the feasibility and acceptability of an 8-week mindful eating and yoga intervention for adults with overweight/obesity?
- Does the program bring about changes in mindfulness, dietary behaviors, and physical activity?
- Does the program lead to positive changes in body composition, and key biomarkers of blood sugar and lipids assessed via a blood panel using a finger stick procedure (no venous blood draw).
Researchers will compare the 8-week mindful eating and movement intervention to a waitlist control group.
Participants will:
Be assigned to the 8-week intervention or waitlist group. Participate 2x/week in the mindful eating and movement sessions. Complete assessments of feasibility and acceptability as well as self-report and objective assessments describe above.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Mindful eating and movementParticipants will engage in group mindful eating sessions 1x/week for 75 minutes. Participants will be encouraged to attend at least 2x/week, 45-minute yoga sessions. |
| Waitlist Control | No intervention | –Participants assigned to the waitlist control group will complete all baseline and follow-up assessments at the same time as the intervention group. They will receive the same 8-week program after the completion of all assessments by all participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- >18 years of age
- Body Mass Index (BMI) > 27 kg/m2
- Ambulatory
- Ability to read, write, and understand English
- Intention to remain in the Boston area for the duration of the study
Key exclusion criteria (13 listed)
- < 18 years of age
- BMI < 27 kg/m2
- Non-ambulatory (i.e., use of walkers, wheelchairs)
- Participation in a weight loss study in the past 12 months
- Currently enrolled in a different physical activity or nutrition study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful eating and movementGroup mindful eating sessions will be conducted once per week, one hour per session, for eight weeks. Participants will be encouraged to attend at least two, 45-minute yoga sessions per week. | Behavioural | Intervention Group |
Primary outcome
Feasibility
Time frame: Primary endpoint: 8-weeks
Defined as achieving the target recruitment sample in a 12-month period, 80% retention, 70% attendance rate, and no serious adverse events.
Acceptability
Time frame: Primary endpoint: 8-weeks
Defined as >5/7 on acceptability questionnaire (1 = unacceptable, 7 = very acceptable)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha P Gothe, PhD, MA, MS principal investigator
Northeastern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful eating and movement in people with Obesity, run by Northeastern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: Primary endpoint: 8-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.